Tolerability at One Year of Ovarian Function Suppression (OFS) Using Leuprolide and Letrozole. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

The tolerability at one year of ovarian function suppression (OFS) using leuprolide and letrozole in this patient population. Specifically, the number of patients who discontinued treatment prior to one year due to toxicity.

Original Primary Outcome Measures ICMJE (submitted: May 15, 2009)

To determine the tolerability at one year of ovarian function suppression (OFS) using leuprolide and letrozole in this patient population. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

The Effect of OFS Combined With Aromatase Inhibitor Therapy on the Incidence and Severity of Menopausal Symptoms, Sexual Dysfunction, Musculoskeletal Complaints, Other Side Effects and Overall Quality of Life. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

OFS combined with aromatase inhibitor therapy on the incidence and severity of menopausal symptoms, sexual dysfunction, musculoskeletal complaints, other side effects and overall quality of life in this population.

Original Secondary Outcome Measures ICMJE (submitted: May 15, 2009)

To explore the effect of ovarian function suppression (OFS) combined with aromatase inhibition combined with intravenous bisphosphonate therapy on bone mineral density in this patient population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

To evaluate the effect of OFS combined with aromatase inhibitor therapy on the incidence and severity of menopausal symptoms, sexual dysfunction, musculoskeletal complaints, other side effects and overall quality of life in this population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Extended Endocrine Therapy for Premenopausal Women With Breast Cancer

Official Title ICMJE

Extended Endocrine Therapy for Premenopausal Women With Breast Cancer

Brief Summary

The purpose of this study is to determine the safety and tolerability of the combination of two drugs (letrozole and leuprolide) in women who have already taken tamoxifen for at least 4.5 years. Letrozole, an aromatase inhibitor (which blocks an enzyme that produces estrogen), is a drug that is FDA approved. It has been shown to reduce the risk of breast cancer recurrence in postmenopausal women with breast cancer who have been previously treated with tamoxifen. Letrozole works by stopping the production of estrogen in parts of the body other than the ovaries. Leuprolide is a drug that stops a women's ovarian cycles. This process is known as ovarian function suppression. Stopping a women's menstrual cycle may be effective against breast cancer for some patients when given as initial therapy. The combination of letrozole and leuprolide is considered a standard treatment for women with metastatic breast cancer, and is also sometimes used for treatment of premenopausal early stage breast cancer, but it has not been accepted as a standard of care treatment.

Detailed Description

Participants will be given a monthly intramuscular injection of leuprolide. Six to eight weeks after the first leuprolide injection, participants will be instructed to begin taking letrozole pills by mouth at home each day.

During this research study, participants will also be offered injections of zoledronic acid to preserve bone mineral density. If desire, these injections will be given every 6 months for a total of 4 injections during the course of the research study.

The treatments in this research study may increase the risk of bone density loss, so vitamin D and calcium supplements will be recommended to participants.

The following tests and procedures will be performed during the research study: Physical Exam (every visit); Blood tests; Urine test (beginning and end of treatment); Imaging (annual mammograms); Bone Density (DXA) Scan (beginning and end of treatment); Questionnaires (throughout the study).

Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years

Other Name: Lupron

Drug: letrozole

Taken orally once a day 6-8 weeks after initial leuprolide administration

Other Name: Femara

Drug: zoledronic acid

If desired, given intravenously every 6 months for a total of 4 injections (optional)

Other Name: Zometa

Study Arm (s)

Experimental: Letrozole-Leuprolide

Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.

Interventions:

Drug: leuprolide

Drug: letrozole

Drug: zoledronic acid

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

17

Completion Date

September 2014

Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Women 18 years of age or older

History of invasive ER+ or PR+ breast cancer treated with at least 4.5 years of tamoxifen

No current evidence of recurrent invasive disease or metastatic disease. Patients may have a history of bilateral breast cancer